Back to resultsProtective Effects of Edaravone Dexborneol
Primary Purpose
Acute Ischemic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
edaravone dexborneol or edaravone
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring edaravone dexborneol, ischemic penumbra, NIHSS, mRS
Eligibility Criteria
Inclusion Criteria:
- Aged from 50 to 80 years old;
- Patients diagnosed as acute ischemic stroke according to Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018 and who met the requirements of middle cerebral artery blood supply area infarction (except deep perforator disease) without treatment;
- Brain MR showed that the low perfusion area of ASL was at least 20% larger than that of DWI core infarct area, and the contralateral mirror brain tissue was basically normal;
- NIHSS score was between 4 to 24;
- Patient or their legal representatives were willing to sign the informed consent form.
Exclusion Criteria:
- Serious mental abnormality, complicated with heart, lung, liver, renal insufficiency or malignant tumor and other serious diseases;
- Combined with cerebral vascular malformation or cerebral hemorrhage;
- Pregnant or lactating women;
- Allergic to edaravone or dexborneol;
- There are interactions between the drugs being taken by patients and the study drug or affect the clinical trial parameters.
Sites / Locations
- Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
edaravone dexborneol group
edaravone group
Arm Description
Outcomes
Primary Outcome Measures
image changes in different groups
Secondary Outcome Measures
NIHSS changes in different groups
mRS changes in different groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05024526
Brief Title
Protective Effects of Edaravone Dexborneol
Official Title
Protective Effects of Edaravone Dexborneol in Patients With Acute Ischemic Stroke by Improving Ischemic Penumbra and Collateral Circulation of Hypoperfusion Areas
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lili Cao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The patients of acute ischemic stroke were divided into two groups, edaravone dexborneol treatment group and edaravone treatment group. The purpose of this study was to observe the changes of imaging and the improvement of NIHSS and mRS in different groups.
Detailed Description
A total of 80 patients with acute ischemic stroke of middle cerebral artery were randomly divided into two groups, edaravone dexborneol treatment group and edaravone treatment group. The mismatch area between the low perfusion area of MRI 3D-ASL and the infarct area of DWI was defined as the ischemic penumbra, and the CBF perfusion pseudo color images with PLD of 1.5s and 2.5s were recorded. The above two CBF perfusion images were subtracted, and the residual area was quantitatively analyzed to reflect the establishment of collateral circulation. We aimed to observe whether there were differences in the improvement of ischemic penumbra and the establishment of collateral circulation between two groups after treatment. Besides, the improvment of NIHSS and mRS was also observed in different periods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
edaravone dexborneol, ischemic penumbra, NIHSS, mRS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
edaravone dexborneol group
Arm Type
Experimental
Arm Title
edaravone group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
edaravone dexborneol or edaravone
Intervention Description
Edaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy.
Primary Outcome Measure Information:
Title
image changes in different groups
Time Frame
7 days
Secondary Outcome Measure Information:
Title
NIHSS changes in different groups
Time Frame
7days，14 days, 90 days
Title
mRS changes in different groups
Time Frame
7days，14 days, 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged from 50 to 80 years old;
Patients diagnosed as acute ischemic stroke according to Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018 and who met the requirements of middle cerebral artery blood supply area infarction (except deep perforator disease) without treatment;
Brain MR showed that the low perfusion area of ASL was at least 20% larger than that of DWI core infarct area, and the contralateral mirror brain tissue was basically normal;
NIHSS score was between 4 to 24;
Patient or their legal representatives were willing to sign the informed consent form.
Exclusion Criteria:
Serious mental abnormality, complicated with heart, lung, liver, renal insufficiency or malignant tumor and other serious diseases;
Combined with cerebral vascular malformation or cerebral hemorrhage;
Pregnant or lactating women;
Allergic to edaravone or dexborneol;
There are interactions between the drugs being taken by patients and the study drug or affect the clinical trial parameters.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Qing Fang, MD
Phone
+8618866883808
Email
perfectin2000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Qing Fang, MD
Organizational Affiliation
Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shandong Provincial Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Cao, Ph.D
Email
qykyc309@163.com
First Name & Middle Initial & Last Name & Degree
Yu-Qing Fang, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Protective Effects of Edaravone Dexborneol
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